Clinical Research Nurse

Job Description

Job Description

Biotrial, a leading provider of high-quality pharmacology services, is recruiting a Full-time Licensed Practical Nurse (LPN) to work in it Clinical Research Pharmacology Unit in Newark, New Jersey, the Company’s US headquarters. Benefits available for full-time employees.

Position Summary:

As an LPN you will work under the guidance of the Pharmacology Unit Director, Principal Investigator and Sub-Investigators and in coordination with the Biotrial Clinical Project Team to perform procedures required in clinical research studies conducted on behalf of sponsors. Must ensure that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations.

Responsibilities:

• Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.

• Implement study procedures in compliance with accepted research guidelines including Health Insurance Portability and Accountability Act (HIPAA) regulations and the study protocol.

• Participate in the review and validation of the study CRFs in conjunction with the Investigator, Clinical Research Nurse, and the Clinical Research Associate of the Study.

• Perform study procedures (e.g., participate in screening procedures, prepare and administer infusions under the supervision of a pharmacist or physician, start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc., and pharmacodynamic measures - psychometric tests, etc.), process blood samples as required by study protocol under the supervision of the Principal Investigator.

• Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness.

• Assist in transcribing study data from source documents to sponsor designated case report forms or record data for remote data entry if applicable.

• Resolve data queries in conjunction with the sponsor.

• Assist the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.

Requirements:

• An active LPN license in the State of New Jersey and IV experience preferred, but not required.

• Minimum of 3 years’ experience as a LPN.

• Knowledge of FDA regulatory requirements is necessary, ex. CITI

• Excellent communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, Biotrial Clinical Project Team and Sponsor personnel.

• Excellent communications skills with ability to interact with Sub-Investigators, Project Team and Sponsors.

• Good working knowledge of Microsoft Office Suite including Word and Excel.

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

• Ability to speak effectively before sponsors, patients and employees of organization.

• Knowledgeable of clinical research process preferred but not required.

• Ability to work independently, efficiently and accurately with high productivity.

• Experience in conducting complex long-term projects and meeting strict timelines.

• Good interpersonal skills .

Biotrial possesses one of the largest clinical capacities in Europe. The company’s new, 60,000 sq. ft., 118-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.

Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.

Work Remotely

• No

Job Type: Full-time

Benefits:

• 401(k)

• 401(k) matching

• Dental insurance

• Health insurance

• Paid time off

• Referral program

• Vision insurance

Application Question(s):

• Are you seeking full-time employment?

License/Certification:

• BLS Certification (Preferred)

• Active New Jersey LPN license (Required)

• IV certification (Preferred)

Work Location: In person